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(2)

This presentation includes forward-looking statements that involve risks,

uncertainties and other factors, many of which are outside of our control

that could cause actual results to differ materially from the results discussed

in the forward-looking statements. Forward-looking statements include

statements regarding our short-term objectives and opportunities, financial

expectations for the full year and financial preparedness as of year end, as

well as statements concerning our plans, objectives, goals, future events,

performance and/or other information that is not historical information. All

such forward-looking statements are expressly qualified by these cautionary

statements and any other cautionary statements which may accompany the

forward-looking statements. We undertake no obligation to publicly update

or revise forward-looking statements to reflect subsequent events or

circumstances after the date made, except as required by law.

(3)

BAVARIAN NORDIC

CANCER IMMUNOTHERAPIES AND VACCINES FOR INFECTIOUS DISEASES

FACTS

BAVARIAN NORDIC IN BRIEF

• Vertically integrated multinational biotech company

• Revenue-generating

• Leader in vector-based active immunotherapy

• First product approved in 2013

• Three Phase 3 programs: Prostate cancer, Ebola and smallpox

• Commercial scale cGMP manufacturing facility

• Long-term R&D and delivery contracts with the US government

Founded 1994, IPO 1998

Listed on Nasdaq Copenhagen: BAVA 28m shares outstanding

(4)

MULTIPLE LAYERS OF VALUE

Validated Platform Technology (NIH, BARDA, BMS, Janssen)

1 approved product 7 active programs

3 Phase 3 Products

Multiple near-term milestones

$1.2B in US government contracts

$950M in revenues over past 10 years $975M BMS deal - PROSTVAC

$358M Janssen deals – Ebola and HPV

Expertise in T-Cell Stimulation & Antibody Response

Strong Revenue Base to Re-Invest in Clinical Pipeline

2 focus areas

Infectious Disease & Oncology

Broad Pipeline & Late-Stage Candidates

(5)

RESEARCH AND PRODUCTION AT THE FOREFRONT.

Headquarters &

Large scale manufacturing Kvistgård, Denmark

• 9,000sqm multiproduct manufacturing

facility, QA/QC and administration

• Approx. 270 employees

Martinsried Germany

• R&D facilities located in the “Biotech Region of Munich” - one of the leading biotech regions in Europe • Approx. 110 employees Redwood City, CA USA • Clinical development situated close to recognized universities that are leaders within cancer immunology.

(6)

Commercial Production Facility

• Inspected by the EMA and the FDA

• 28M doses of IMVAMUNE delivered to US

national stockpile

• Over 2M doses of MVA-BN Filo (Ebola)

delivered to Janssen

Poxvirus Manufacturing Expertise

• Commercial partnerships in place with

Janssen & BMS

• All manufacturing performed by BN

• Company has developed IP and extensive

know-how in the production of poxvirus based vaccines

COMMERCIAL MANUFACTURING CAPABILITIES

Multi-Product Facility

• Highly scalable, fully integrated, reduces

dependency on sub-contractors

• Fill/Finish established to support commercial

launch of PROSTVAC

(7)

CLINICAL PIPELINE

PRODUCT CANDIDATE INDICATION COMMERCIAL RIGHTS PRIMER / BOOSTER PRECLINICAL PHASE 1 PHASE 2 PHASE 3 APPROVED STATUS / EXPECTED MILESTONES

Infectious Disease

IMVAMUNE / IMVANEX

(LIQUID FROZEN)

Smallpox MVA-BN MVA-BN  Approved in Canada and the

European Union

Smallpox MVA-BN MVA-BN Complete enrollment in 2017

IMVAMUNE

(FREEZE DRIED) Smallpox

MVA-BN

MVA-BN  Manufacturing validation

MVA-BN Filo Ebola / Marburg AdVac(a)

MVA-BN  Data from multiple trials in 2016

MVA-BN RSV RSV MVA-BN MVA-BN  Phase 1 trial data in 1H16

HPV Vaccine HPV AdVac(a)

MVA-BN  Deal signed in December 2015

Cancer Immunotherapy

PROSTVAC mCRPC Vaccinia Fowlpox  Three interim analyses likely starting in 1Q16

with top-line data in 2017

Localized Prostate Cancer Vaccinia Fowlpox  NCI enrolling Phase 2 trial Localized Prostate Cancer

(neoadjuvant)

Vaccinia

Fowlpox  NCI Phase 2 trial data in 2016

Non-Metastatic Castration Sensitive Prostate Cancer

Vaccinia

Fowlpox  NCI enrolling Phase 2 trial

mCRPC Vaccinia Fowlpox  NCI enrolling Phase 2 trial

Metastatic Castration

Sensitive Prostate Cancer Vaccinia Fowlpox  NCI enrolling Phase 2 trial Non-Metastatic Prostate

Cancer

Vaccinia

Fowlpox  NCI Phase 2 trial data in 1H16

Prostate Cancer Vaccinia Fowlpox NCI Phase 1 trial enrollment complete

CV 301 Bladder Cancer Vaccinia

(c)

Fowlpox  NCI enrolling Phase 2 NCI trial

MVA-BN Brachyury Solid Tumors MVA-BN

MVA-BN(d)  Phase 1 data reported in 4Q15

(b) (b) (b) (b) (b) (b)

Approved in Canada and the European Union Phase 3 in US (non-inferiority)

Phase 2 complete

Fully enrolled

PROSPECT fully enrolled

+ XTANDI (enzalutamide)

+ XTANDI (enzalutamide) ipilimumab

+ ADT and docetaxel

(b) (b)

(8)

2015/2016 HIGHLIGHTS

• Global commercialization agreement for PROSTVAC with Bristol-Myers Squibb –

potential value of $975M including option and milestone payments and $60M upfront.

• Product license agreement with Janssen (Johnson & Johnson) for MVA-BN HPV - $9M

upfront, & potential of 162M in development & sales milestones

PARTNERSHIPS

$181M vaccine supply and R&D contracts from the US government

• $15M expansion of NIH contract for Filovirus vaccine development (June 2015)

• $133M IMVAMUNE bulk order received by BARDA (July 2015)

• $33M R&D MVA-BN Filo BARDA contract (subcontractor to Janssen award)

(9)

2015/2016 HIGHLIGHTS

CONTINUED

Multiple clinical studies initiated

• MVA-BN RSV Phase 1 in U.S.

• PROSTVAC Phase 2 active surveillance study in men with localized prostate cancer

• PROSTVAC + docetaxel combination Phase 2 study in metastatic prostate cancer

(2016)

• PROSTVAC Phase 2 study in non-metastatic castration sensitive prostate cancer (2016)

• PROSTVAC first interim analysis has occurred; study continues as planned (2016)

• Ebola prime boost phase 3 study

• Reported pivotal Phase 2 & 3 IMVAMUNE data

• Reported long-term survival Phase 1 data of combination of PROSTVAC and

ipilimumab

• Reported Phase 1 Brachyury data in 38 patients with advanced cancer

• Reported Phase 1 Ebola data

(10)
(11)

SUCCESSFUL PARTNERSHIP WITH THE U.S. GOVERNMENT

CONTRACTS AWARDED TO-DATE EXCEED US$ 1.2 BN

Developing, producing, supplying liquid-frozen IMVAMUNE®

Developing freeze-dried vaccine Expanding MVA-BN® platform

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 RFP-1 IMVAMUNE Smallpox Vaccine US$ 14m NIH RFP-3 IMVAMUNE Smallpox Vaccine US$ 500m BARDA RFP-2 IMVAMUNE Smallpox Vaccine US$ 100m NIH RFP-2 Expansion IMVAMUNE Smallpox Vaccine US$ 16m NIH RFP-3 Expansions IMVAMUNE Smallpox Vaccine US$ 49m BARDA RFP Freeze Dried IMVAMUNE Smallpox Vaccine US$ 40m BARDA RFP Freeze Dried Expansion US$ 55m BARDA MVA-BN Marburg US$ 18m NIH MVA-BN Foot-and-mouth disease US$ 1m DHS Delivery contract IMVAMUNE Smallpox Vaccine US$ 228m BARDA 2013 2014 MVA-BN Burkholderia US$ 500k DOD DTRA Bulk Order IMVAMUNE Smallpox Vaccine US$ 133m BARDA 2015 MVA-BN Marburg Expansion US$ 15m NIH MVA-BN Ebola Subcontract US$ 33m BARDA

(12)

Recent events continue to drive confidence

• Phase 2 complete

• Manufacturing activities ongoing to support an EUA

• RFP expected to be issued by USG

• USD 133 million bulk order from BARDA (July 2015)

• Initial order allows for immediate transition to FD once RFP occurs and FD pricing can be established

Potential

• First wave of replenishment could replace

20 million expiring doses in stockpile

• Long term stated goal of US Government calls for

non-replicating vaccine for 66 million US citizens (~132 million doses)

IMVAMUNE

(13)
(14)

PSA

CEA, MUC-1 HER-2 Brachyury

Tumor antigens with epitopes enhanced for HLA binding Prostate, lung, head & neck, bladder, colorectal, breast, ovarian and renal cancers

TRICOM

(TRIad of COstimulatory Molecules)

Enhance T-Cell activation in synergistic manner

Strengthen the anticancer immune response

TRICOM

TAA LFA-3 ICAM-1 B7.1 Heterologous prime/boost regimen Vaccinia or MVA + Fowlpox Subcutaneous administration

V

F

Safe and well tolerated (11 clinical trials)

Injection site reactions and flu-like symptoms

PROSTVAC

(15)

PROSTVAC INDUCES AN ANTIGEN CASCADE AGAINST

PROSTATE CANCER CELLS

Test Result Comment

PSA-Specific Immune response 56.7% (59/104) 28 days after last vaccine

Median fold increase in

PSA-specific immune response 5X

PSA response 30 / 106 cells

flu response 33 / 106 cells

Antigen Cascade 67.9% (19/28)

Anti-PSA Ab 0.57% (2/349)

(16)

PROSTVAC PHASE 3 STUDY

18,4% 17,7% 38,2% 25,7%

Randomization by region (N=1,297)

USA, Canada Belgium, Denmark, France, Germany,

Iceland, Netherlands, Spain, United Kingdom

Australia, Estonia, Israel, Poland, Russia North America Urology (n=229) North America Oncology (n=239) Rest of World (n=333) Western Europe (n=497)

Injections

1) Subjects who have completed study treatment phase or have completed 7th

dosing visit. N=1,279

• Average was 6.1 injections1

• Randomized Phase 2 trial (n=122) had

average of 5.4 injections2

• An increased number of injections is expected to improve the clinical outcome for patients receiving the active drug.

2) Kantoff et al., Journal of Clinical Oncology, January 2010

PROSTVAC + GM-CSF PROSTVAC Placebo

3 study arms

PROSPECT

A Randomized, Double-blind, Global Phase 3 Efficacy Trial of PROSTVAC in Metastatic

(17)

ENTRY CRITERIA

Randomized Phase 2 PROSPECT Phase 3

ECOG < 2

No visceral metastases

Asymptomatic (no cancer-related pain requiring narcotics) No prior chemotherapy

• Gleason score < 7 (from original biopsy)

• Removed Gleason score exclusion

− Gleason grade not associated with treatment effect

in other phase 3 mCRPC trials (sip-T, ipilimumab)

• No alkaline phosphatase exclusion • Changed to exclude patients with alk phos > 2 times ULN

− Excludes more advanced metastatic disease

• No LDH exclusion • Changed to exclude patients with LDH > 2 times ULN

− Excludes more advanced metastatic disease

• No PSA doubling time (PSA-DT) exclusion Added exclusion for patients with PSA-DT < 1 month

− Excludes patients with fast growing tumors

• Minimum PSA value for determination of CRPC = 5

ng/mL (PCWG1)

• Minimum PSA value for determination of CRPC lowered to 2 ng/mL (PCWG2)

(18)

First interim analysis of the PROSPECT Phase 3 study has occurred

• A recent review by the Data Monitoring Committee informed BN to “Continue the

trial without modification”

• Interim 1 was an analysis of each of the active PROSTVAC arms (with or without

GM-CSF) versus placebo, thus requiring at least 214 events per comparison (equals 40% of the 534 events required for final overall survival analysis)

• 2 additional interim analyses remain

• Final overall survival data anticipated in 2017

PROSTVAC: INTERIM ANALYSES UNDERWAY

Interim Analysis #1 214 events 40%

Interim Analysis #2 321 events 60%

Interim Analysis #3 427 events 80%

Final Overall Survival Analysis 534 events 100%

(19)

DEMONSTRATED POTENTIAL AS A COMBINATION

THERAPY WITH BMS’ IPILIMUMAB

0 12 24 36 48 60 Su rv iv al (% of p at ie nt s) 0 20 40 60 80 100 16.6 months 25.1 months Months 0 24 48 72 Su rv iv al (% of pa tie n ts) 0 20 40 60 80 100 PROSTVAC + Ipi (all Ipi dose cohorts)

31.6 months Months Patients in 10mg/kg dose cohort (N=15) reported 37.2 months median overall survival ~20% of 10mg/kg patients remain alive at 80 months

PROSTVAC Phase 2 Trial PROSTVAC + Ipilimumab Phase 1 Trial

(20)

Further investigation of PROSTVAC in collaboration with BMS

• Two new investigator-sponsored trials planned for initiation

PROSTVAC COMBINATION TRIALS

TWO NEW TRIALS PLANNED FOR INITIATION

PROSTVAC ipilimumab PROSTVAC + ipi

Open label combination trial in localized prostate cancer using PROSTVAC and ipilimumab as neoadjuvant therapy. Phase 2 (n=75) Sponsor: UCSF Clinicaltrials.gov NCT02506114 Randomization 1:1:1

PROSTVAC + ipi + nivo PROSTVAC + ipi

Open label combination trial in prostate cancer using

PROSTVAC, ipilimumab and

nivolumab as neoadjuvant therapy

Phase 2

(n=28)

(21)

STUDIES SPAN PROSTATE CANCER DISEASE LANDSCAPE

docetaxel ADT

surgery

Hormone dependent Castration resistant

No pain Pain Nonmetastatic Metastatic Phase 3 (BN) enza combo (NCI) flutamide combo (NCI)

abi, enza, Ra-223, cabazitaxel sip-T, enza, abi, Ra-223 Active surveillance (NCI) Neoadjuvant (NCI) enza combo (NCI)

death Tumor volume

Mechanism of action (MOA)

• Immune infiltration to tumor, immune response, biomarkers, and PSA kinetics

Use in combination

• With currently approved therapies for mCRPC, and with checkpoint inhibitors

Use in earlier prostate cancer to support future label expansion

mono (NCI)

ADT + docetaxel combo (NCI)

(22)

Elements

Value

Upfront payment

$60M

License

$80M

Phase 3 data

$50M

Data-driven milestones

$180M*

Regulatory milestones

$110M

Sales milestones

$495M

Tiered royalties on future sales

High teens up to mid-twenties

COMMERCIAL LICENSE WITH BMS

(23)
(24)

New and improved vaccine construct based on MVA-BN

CV-301

CV-301 FOR MULTIPLE CANCERS

MUC-1

CEA Lung, Breast, Colorectal, Ovarian,

Gastric, Bladder, Liver and Renal cancer MVA-BN Fowlpox TRICOM

+

=

CV-301 development strategy

• Combination treatment with checkpoint inhibitor(s)

• Short-term clinical outcomes possible (Overall Response Rate, Progression-Free Survival)

• Partnering opportunity based on proof-of-concept data

(25)

COMPLETE TUMOR REGRESSION FROM POXVIRUS-BASED

IMMUNOTHERAPY COMBINED WITH PD-1 & LAG-3

BLOCKADE

Control anti-PD1 + 14/20 anti-LAG3 MVA-BN-HER2 2/20 MVA-BN-HER2 20/20 + anti-PD1 + anti-LAG3

CT26-HER2 solid tumor model:

MVA-BN-HER2 immunotherapy (s.c.) and/or PD1 + anti-LAG3 antibody (i.p.)

Q2wks x2 (d1 and 15) C o n t r o l T u m o r V o lu m e (m m 3 ) 0 1 0 2 0 3 0 4 0 0 1 0 0 2 0 0 3 0 0 4 0 0 5 0 0 M V A -B N - H E R 2 T u m o r V o lu m e (m m 3 ) 0 1 0 2 0 3 0 4 0 0 1 0 0 2 0 0 3 0 0 4 0 0 5 0 0 M V A -B N - H E R 2 + a n t i- P D -1 + a n ti-L A G -3 T u m o r V o lu m e (m m 3 ) 0 1 0 2 0 3 0 4 0 0 1 0 0 2 0 0 3 0 0 4 0 0 5 0 0 a n t i- P D - 1 + a n ti-L A G -3 T u m o r V o lu m e (m m 3 ) 0 1 0 2 0 3 0 4 0 0 1 0 0 2 0 0 3 0 0 4 0 0 5 0 0

Durable Response

After Mice Were

Re-Challenged

(26)

CV-301 PRODUCT DEVELOPMENT STRATEGY

Preliminary evidence of efficacy generated in multiple clinical studies. Safety data with over 300 subjects treated.

Leverage Existing

Clinical Data

CV-301 in Combination with Immune

Checkpoint Inhibitors

NCSLC

Bladder

Colorectal

BN sponsored Exploring combinations with PD-1/PD-L1 in company collaborations or with NCI

(27)
(28)

Janssen Deal

Clinical Status

Additional Commercial

Targets

• $45M licensing agreement

grants Janssen full

commercialization rights

• BN eligible to receive

royalties outside of Africa

• Additional supply

agreement of $99M

• Equity investment of $43M

(~5% of BN)

• Janssen presented

preliminary Phase 1 data in May 2015

• Multicenter Phase 2

clinical trial initiated in July 2015 in the United Kingdom and France

• Phase 2 trial (n=1,200)

and a Phase 3 trial have been initiated in Africa

• Data expected in 2016

• Entered into subsequent

$171M agreement with Janssen for a therapeutic HPV vaccine in December 2015

• Two additional

undisclosed targets also being explored

• MVA-BN is a promising

booster to existing Janssen technology (AdVac from Crucell)

MVA-BN FILO: OUR PHASE 3 EBOLA VACCINE PARTNERED

WITH JANSSEN

(29)

29

FIRST IN HUMAN DATA FOR THE BAVARIAN

NORDIC/JANSSEN EBOLA PRIME-BOOST VACCINE

• 72 healthy volunteers

randomized into four groups receiving prime-boost vaccine regimen or placebo at intervals of 28 or 56 days

• An open-label arm with 15

healthy volunteers is also investigating a shorter prime-boost interval of 14 days for Ad26.ZEBOV

prime and MVA-BN Filo boost

Phase 2 & 3 Clinical Trials Ongoing in the US, EU and Africa

AdVac + MVA-BN Provides Durable Response

0 50 100 150 200 10 100 1000 10000 100000 Antibodies (ELISA) Days E L I S A U n i t s / m l 0 50 100 150 200 0.01 0.1 1 10 CD8+ T cells (ICS) Days T o t a l c y t o k i n e r e s p o n s e ( % o f s u b s e t ) 0 50 100 150 200 10 100 1000 10000 100000 Antibodies (ELISA) Days E L IS A U n it s/ m l 0 50 100 150 200 0.01 0.1 1 10 CD8+ T cells (ICS) Days T ot al cy to ki n e re sp o n se (% o f su b se t) Ad26/MVA 0, 28 Ad26/MVA 0, 56

(30)

Subsequent to the Ebola collaboration, BN and Janssen

agreed to collaborate on three additional infectious

disease targets

The first indication now licensed with Janssen

A therapeutic vaccine for individuals with an active human papillomavirus

(HPV) infection

• Novel approach for early treatment and interception of HPV-induced cancers

• High-risk HPV types cause approximately 5 percent of all cancers worldwide

EXPANSION OF JANSSEN COLLABORATION: HPV VACCINE

$171M AGREEMENT SIGNED IN DECEMBER 2015

MVA-BN HPV deal structure

• Total potential agreement value $171 million including $9 million upfront plus milestone payments and single-digit royalties on sales

• Janssen expected to initially focus on infected women at risk for cervical cancer, and then head and neck cancers

(31)
(32)

Development strategy

Elderly +Adults at risk

Children >5yrs Phase 1- Enrolled Phase 1/2

2015

Phase 2- Initiate H2

2016

RSV: Respiratory Syncytial Virus

• No approved vaccine; high unmet medical need

• Responsible for a similar number of deaths as the flu in children up to 14, as well as in the elderly population

• Results in a high number of hospitalizations

MVA-BN RSV vaccine candidate

• Demonstrated strong immune response

• Blood and mucosal protection (key differentiator)

• Protection against both RSV subtypes (A&B) in preclinical models

COMMERCIAL VACCINES: RSV

(33)

MVA-BN RSV BOOSTS PRE-EXISTING RESPONSES

1 10 100 1000 10000 100000 Anti -RS V Anti bodi es in blo od (GMT) 1 10 100 1000 10000 100000 An ti -RSV anti bo dies in t he muco sa (GMT

) Anti-RSV antibodies induced

by a previous RSV infection Anti-RSV antibodies boosted by a single vaccination with MVA-BN RSV

0 2

Weeks

0 2

Weeks

Anti-RSV antibodies measured by ELISA (Enzyme-linked immunosorbent assay)

• Animals that had previously been infected (and survived) an RSV infection were

vaccinated at week 0.

• Model mimics the situation of adults that have all been exposed to RSV

• Antibodies against RSV were boosted >7-fold & >75-fold in the blood and mucosa (lung) following a single vaccination with MVA-BN RSV

(34)

• Fully enrolled Phase 1, randomized, single-blind, monocenter, placebo controlled

• Healthy subjects, 18 – 65 years of age, N = 63

Primary objective: Safety and reactogenicity of MVA-mBN294B (MVA-BN RSV vaccine)

Secondary objective: RSV-specific (ELISA, PRNT, ELISPOT/ICS) and vaccinia-specific immune response to MVA-BN-RSV vaccine

MVA-BN RSV PHASE 1 INITIATED IN THE UNITED STATES

Groups N Age (years) Vaccine Dose per 0.5 ml

(nominal titers)

Schedule (Days)

1 18+3 18-49 MVA-BN RSV /placebo 1 x 107 TCID

50 0-28

2 18+3 18-49 MVA-BN RSV /placebo 1 x 108 TCID

50 0-28

3 18+3 50-65 MVA-BN RSV /placebo 1 x 108 TCID

50 0-28

Total 54+9 = 63

(35)
(36)

MVA-BN BRACHYURY

NOVEL IMMUNOTHERAPY CANDIDATE WITH BROAD POTENTIAL

Indications

• Chordoma (ultra-orphan disease)

• Triple negative breast cancer

• NSCLC

• Multiple solid tumors

Development Strategy

• NCI Phase 1 and Phase 2 studies

• NCI Phase 2 chemotherapy combination

study(s)

• NCI erlotinib combination study(s)

• NCI and BN immune checkpoint inhibitor

combinations

• Brachyury expression is highly correlated with metastatic disease, and multi-drug

resistance.

• Brachyury is not expressed in most normal tissue.

• Brachyury is responsible for epithelial to mesenchymal transition (EMT) which is a major driver of metastasis.

(37)

These findings show for the first time that advanced cancer patients can be safely immunized with an MVA-based vaccine targeting brachyury, and can develop

brachyury-specific T-cell immune responses.1

MVA-BN BRACHYURY: PHASE 1 DATA

38 patients with advanced cancer (N=25) or chordoma (N=13)

• Advanced cancers included Colorectal, Breast (ER+) NSCLCa (EGFR mutated),

Prostate, Pancreatic, Ovarian and Cholangiocarcinoma.

Dose escalation, safety and immunogenicity study

• No SAE’s associated with vaccine

• At DL2 and DL3, ~80% of the patients that demonstrated brachyury-specific T-cells

demonstrated responses in both CD4 and CD8 T-lymphocytes

Dose Level Dose and Schedule

1 (N=3) 1 site of injection at 2 x 108 IU given every 28 days for 3 doses. 2 (N=17) 2 sites of injection at 2 x 108 IU given every 28 days for 3 doses. 3 (N=18) 4 sites of injection at 2 x 108 IU given every 28 days for 3 doses.

(38)
(39)

FINANCIAL PERFORMANCE

• Revenues of more than DKK 1bn for the fourth consecutive year

• Break-even result for third consecutive year

• Cash preparedness doubled since 2013

-1000 100 200 300 400 500 600 700 800 900 1.000 1.100 1.200 1.300 2012 2013 2014 2015 Revenue EBIT

Revenue & EBIT (DKKm)

0 200 400 600 800 1.000 1.200 1.400 1.600 2012 2013 2014 2015

Cash preparedness (DKKm)

Cash preparedness

(40)

mDKK mUSD

2015 guidance actual guidance actual

Revenue 1,000 1,021 146 149

EBIT 0 2 0 0

Cash preparedness at year-end 1,450 1,451 212 212

2015 RESULTS IN LINE WITH EXPECTATIONS

• Revenues of more than DKK 1bn

• 762 mDKK; deliveries of MVA-BN Filo to Janssen (112 mUSD)

• 181 mDKK; ongoing R&D contracts (27 mUSD)

• 78 mDKK; sale of IMVAMUNE to USA and rest of world (11 mUSD)

• Break-even result

(41)

2016E mDKK mUSD

Revenue 1,000 146

EBIT 0 0

Cash preparedness at year-end 1,300 190

FINANCIAL OUTLOOK

2016 guidance – another year with break-even expected

• More than 90% of revenues will be recognized in 2H 2016

• 750 mDKK from IMVAMUNE sales (110 mUSD)

• 250 mDKK from R&D contracts (37 mUSD)

• Total R&D costs of 580 mDKK (85 mUSD) of which 475 mDKK (70 mUSD) will be recognized in the P&L

• Ongoing evaluation of financing options based on market conditions, including

previously announced prospective registered public offering in the U.S. of the ADSs, the timing and terms of which have not yet been determined; year-end cash

preparedness does not include proceeds from any prospective share issuance

(42)

prostate cancer

• Interim analyses of Phase 3 study

• Phase 3 top-line data

• Initiate Phase 2 study in combination with

ipilimumab in collaboration with BMS

• Initiate NCI-sponsored Phase 2 study in

combination with ipilimumab and nivolumab

• Data from NCI-sponsored Phase 2 trials

• New NCI-sponsored combination trials

smallpox vaccine

• Finalize manufacturing activities to support a

U.S. EUA for freeze-dried IMVAMUNE

• Initiate manufacturing and storage of IMVAMUNE

bulk for the U.S. Government

• Additional Rest of World orders

• Complete enrollment of Phase 3 non-inferiority

study

projects

• MVA-BN RSV Phase 1 data

• MVA-BN RSV Phase 2 initiation

• MVA-BN Brachyury Phase 2 initiation

• CV-301 + checkpoint inhibitor Phase 2 initiation

in lung cancer

• CV-301 + checkpoint inhibitor Phase 2 initiation

in additional indications

• Initiate NIH-sponsored Phase 1 trial of

multivalent MVA-BN Filo

• Complete Phase 2 and Phase 3 studies of the

Ebola prime-boost vaccine regimen

• Potential expanded collaboration with Janssen

on additional infectious disease targets

ANTICIPATED SELECTED MILESTONES

2016/2017

PROSTVAC

IMVAMUNE

(43)
(44)
(45)

Promoters Co-Stimulatory Molecules (TRICOM) Antigens Recombinant Poxviruses Customized Immunogenicity Antigenic Complexity Low High Simple Complex + Vectors

LIVE VIRUS VACCINE PLATFORM

VALIDATED AND MODULAR APPROACH EMPLOYING POXVIRUSES

Wide Variety of Target Diseases Target Multiple Antigens for a Single Disease

(46)

0,1 1,0 10,0 100,0 1.000,0 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82

PROSTVAC - PATIENT CASE HISTORY (“FRANK”)

PUBLISHED 2013 CASE REPORT IN

CLINICAL GENITOURINARY CANCER

Age PSA

Trend before radical prostatectomy ( ) 5.8 months DT (doubling time)

Trend after radical prostatectomy. External beam radiation ( ) 9.6 months DT

Trend after first vaccine trial ( ) 28.6 months DT

Trend after second vaccine trial ( )

Gleason grade: 4 + 3 = 7 Radical Prostatectomy External Beam Radiation Vaccine Treatment Second Vaccine Treatment

References

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